MAUDE Adverse Event Report: CARDINAL HEALTH MALAYSIA 211 SDN.BHD PURE GRIP POWDER FREE LATEX EXAM GLOVES; LATEX PATIENT EXAM GLOVES

Model Number 1032507

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

As lot number and complaint sample were not available to review device history records, analyze the defect and determine root-cause, corrective or preventive action for this reported failure mode is unable to be defined. the glove manufacturer of this product will continue to ensure that the manufacturing process is stable as well as capable and continuous improvement strategies are implemented in order to ensure gloves are consistently produced according to the required specifications prior to packing and release for shipment.

Event Description

Based on the report received on 10/24/16 approximately two months ago a staff member was wearing these gloves when they had difficulty breathing.They went to the emergency room and was seen by an allergist.Blood tests were done on the staff member, however they did not know the names of the tests.At the time of this report the customer was unable to provide the lot number or a sample.The staff member is doing well.

• Brand Name: PURE GRIP POWDER FREE LATEX EXAM GLOVES
• Type of Device: LATEX PATIENT EXAM GLOVES
• Manufacturer (Section D): CARDINAL HEALTH MALAYSIA 211 SDN.BHD; zone phase iv, mk 12 lintang ,; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): CARDINAL HEALTH MALAYSIA 211 SDN.BHD; zone phase iv, mk 12 lintang ,; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6104078
• MDR Text Key: 59974467
• Report Number: 1423537-2016-00058
• Device Sequence Number: 1
• Product Code: LYY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1032507
• Device Catalogue Number: 1032507
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2016
• Distributor Facility Aware Date: 10/24/2016
• Event Location: Other
• Date Report to Manufacturer: 10/28/2016
• Date Manufacturer Received: 10/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR